Congratulations to 2014 AZBioAwards Winners

BioAwards-2014-PADT- awards1 - CopyLast week, on September 17th, the Arizona Bio Technology community gathered for the 20144 AZBioAwards.  This year PADT was once again privileged to not only attend, but to again 3D Print the awards themselves.   PADT also had a both, which gave us an opportunity to talk with many of our customers who were attending.

This event honors some of the leaders in industry and is a chance for everyone involved to get together and celebrate all the progress that is made each year in this area.

PADT was also pleased to receive recognition for our 20th Anniversary from AZBIO.

You can view a press release about the whole AZBio Week, including the awards, here.

You can see pictures from the event on Facebook, here.

Here is a picture of the awards we made:

BioAwards-2014-PADT- awards2 - Copy

And here is our both with Ward Rand, Josh Heaps, and Andrew Miller interacting with a customer:

BioAwards-2014-PADT- booth5

geoCUBE: Computers for Scanning

PADT just released a line of computer workstations  specifically designed for use with a variety of optical scanners: geoCUBE Scanning Workstations.

Scanning technology has come a long way.  It is relatively easy to scan a real physical part with a variety of different scanning technologies and capture the geometry for use in inspection, design, reverse engineering, or to directly replicate a part with 3D Printing.  The problem is that a good scanner produces a huge  number of data points and a standard office computer, laptop, or even most CAD workstations bog down and perhaps even crash when you try to view or manipulate that much data.  

geocube-hardware-picsWhen we ran into that exact problem here at PADT when we were doing scanning services for customers.  On a nice CAD workstation it was taking almost a whole day to clean up and process a full scan or a large part.  Our manufacturing team asked if they could power one of the CUBE Simulation Computers we use for CFD.  If you know CFD people you know they said “No, but can I also run on your box if you are not using it?”  So they went to our IT staff, the people who design CUBE systems and asked for a custom built machine for scanning.

The result was a breakthrough.  That 20 hour job was finishing in about two hours and we were able to spin the points and the resulting triangle file around on the screen in real time. We liked it so much we decided to come up with four systems spanning the needs of scanning users, and offer them along with the scanner we sell, or to anyone that might need one.

Below is a screen shot of the table showing the four systems, from a basic small box that you can use to drive your scanner, to the power system that we use.  You can download the brochure here, or visit the web page here

geoCUBE-Spec-Table-Screen-Shot

As always, feel free to contact us to get more information and see how we can help you find the right scanner and the perfect computer to go with it.

Scanning Helps Pediatric Heart Surgeon Make Implant Choices

heart-assist-deviceThe week we had the opportunity to help a surgeon make better decisions for their pediatric heart patient.  Dr Stephen Paphal from the Phoenix Children’s Heart Center had a young patient that needed a ventricular assist device. He could implant a device that they knew would fit in the patient, but they also had an alternative, larger device that performs better. The question they needed to answer was: will the larger device fit in the patient?

This surgeon’s team has previously done work using mechanical engineering technology to help them make better decisions, you may have read about their use of 3D Printing to evaluate different treatment options.  They often work with computer models of patients and devices n collaboration with spinal surgeon Dr. Sandro LaRocca in New Jersey, so they had almost all the tools they needed to help this patient.

For this case, they had a computer model of the smaller assist device, and a computer model of the patient’s heart area that they extracted from a CAT scan. Using those two models and visualization software they were able to insert the device model into the body model to verify that the smaller device would fit.

The issue they faced was that they had no computer model for the larger device.  Creating a model the traditional way would take to long. So they called PADT and asked if we could scan the actual object and give them a computer model that they could use.

Just in Time Scanning

One of PADT’s engineer, Johnathon Wright, took the device to our Geomagic Capture blue light scanner to extract a surface model from the real part.  In this image you can see the device being scanned:

heart-assist-scan-on-tableBecause the device is reflective, we covered it with a white powder to get a better scan. That is all the preparation needed.  The part was placed on a very sophisticated rotational displacement device (a $10 Lazy Susan from WalMart) and the scanner is turned on.  The  little reflective dots you can see on the Lazy Susan are used by the scanning software to determine the position of the objects relative to the scanner.

In this image you can see what the part looks like to the scanner:heart-assist-blue-light-scan-1A rectangular pattern of blue light is projected on to the part being scanned, and the included software measures the distortion in the grid to calculate the shape of the object. As you rotate the object (or the scanner) more data is gathered and an accurate point cloud of the external surface is created.

Here is what the point cloud looks like when the scan is completed:

heart-assist-scan-data

In about an hour, Johnathon was able to go from “can you do this” to a water-tight solid that the Doctor could use with his computer model of the patient to see if this larger, better part fit in the patient’s chest.

Here is what the whole setup looks like:

heart-assist-scan-2

Johnathon used Geomagic’s scanning tools running on a PADT CUBE computer that is specifically optimized for scanning to make the process faster and more accurate. In the past, a task like this would have required an expensive and temperamental laser scanner, a dedicated lab, and probably four to eight hours of engineering time to clean up the resulting scan data. As you can see, the device sits on a desktop and requires very little infrastructure or special equipment.

Disruptive Technology

Any day we can help a physician strive for a better surgical outcome is a good day. Beyond that this is also a great example of how three important aspects of the technology enabled us to deliver useful information quickly, making desktop scanning a disruptive technology.

The first key technology is the blue-light scanning itself.  A form of structure-light 3D scanning, this approach uses a blue light because it contrasts the object better. The breakthrough with this technology is that it does not require expensive lasers or complex optics.  Faster computing allows for the complex algorithms used to be quickly and accurately applied.  The approach does not require any special equipment beyond the scanner itself. This results in an affordable device that is easily deployed and operated.  How easy, the 3D motion capture device on the Microsoft Xbox Kinect is a structure-light 3D scanner – using infrared light instead of blue.

Modern software used to convert the scan data into useful information is the second technology deployed for this solution.  In the past the process of calculating the points on a scanned surface, cleaning up spurious data, and converting it to a form that could be easily used was tedious and difficult.  The Geomagic software suite has a modern, intuitive user interface that sits on top of very sophisticated tools that automate many of the steps that used to take us hours to carry out.

The final key technology that makes desktop scanning so disruptive is one that we take for grated today: standards. We were able to produce an STL file from the scan data and the Doctor’s team was able to read that directly in to their visualization software. It is a simple thing, but without standard file formats, transferring so much data would also involve translators which introduce errors and time.

Engineering Better Outcomes

Here at PADT we truly enjoy applying technology developed in the Aerospace or electronics space to other industries, especially medical applications.  This is another great example of how useful engineering tools can be, improving someones life directly.

Build the “Right” Product

Successful product commercialization is achieved when the product development process is integrated with customer development and is executed by an experienced team and organized by an effective process. At PADT we have spent the last 20 years building our team, establishing our infrastructure, and honing our processes. One of the key processes that strongly affect the outcome of a product development effort is the process of establishing product/market requirements. The idealized product development process that we use is shown below and the establishment of requirements is shown as the first development activity box.

product-development-process

Establishing requirements insures that we develop the “Right” product. Building the “Right” product means working closely with clients to understand what the end customers want and are willing to pay for. It also means testing the market by building prototypes early and validating design choices with end customers.

At PADT we have found it very effective to get with customers from the very first meeting to establish these market and product requirements. Even if you are part of a large organization and do not work directly with external customers, we recommend that you adopt a methodology that captures and documents market and product requirements as early as possible, and that you evaluate your design against these requirements through the development process. 

 One way we do this is by asking questions about the product from many perspectives as illustrated by the wheel below. By looking at the product from each of these perspectives, we capture important requirements, avoid late stage product revision, and end up with the “Right” product.

product-development-questions

A question based approach is effective because it opens up everyone involved to looking beyond their initial assumption. The more traditional method of making a list of requirements, often results in requirements from the point of view of the person making the list. By questioning the customer, or proxy customer, from these different points of view, the team looks at things in new and different way and this captures more realistic and comprehensive requirements.

product-development-examples-PADTVisit our case studies page to see examples of how our approach has been used across a wide variety of industries.

The best way to understand the benefits of properly building the right process by establishing product/market requirements is to partner with PADT on your next product development project.

FDA Opening to Simulation Supported Verification and Validation for Medical Devices

FDA-CDRH-Medical-Devices-SimulationBringing new medical device products to market requires verification and validation (V&V) of the product’s safety and efficacy. V&V is required by the FDA as part of their submission/approval process. The overall product development process is illustrated in the chart below and phases 4 and 5 show where verification is used to prove the device meets the design inputs (requirements) and where validation is used to prove the device’s efficacy. Historically, the V&V processes have required extensive and expensive testing. However, recently, the FDA’s Center for Devices and Radiological Health (CDRH) has issued a guidance document that helps companies uses computational modeling (e.g FEA and CFD) to support the medical device submission/approval process.

FDA-Medical-Device-Design-Process-Verification-Validation
Phases and Controls of Medical Device Development Process, Including Verification and Validation
 The document called, “Reporting of Computational Modeling Studies in Medical Device Submissions”, is a draft guidance document that was issued on January 17th, 2014. The guidance document specifically addresses the use of computation in the following areas for verification and/or validation:

  1. Computational Fluid Dynamics and Mass Transport
  2. Computation Solid Mechanics
  3. Computational Electromagnetics and Optics
  4. Computational Ultrasound
  5. Computational Heat Transfer

The guidance specifically outlines what form reports need to take if a device developer is going to use simulation for V&V.  By following the guidance, a device sponsor can be assured that all the information required by the FDA is included. The FDA can also work with a consistent set of input from various applicants. 

drug-delivery-1-large
CFD Simulation of a Drug Delivery System. Used to Verify Uniform Distribution of Drug

Computational Modeling & Simulation, or what we usually call simulation, has always been an ideal tool for reducing the cost of V&V by allowing virtual testing on the computer before physical testing. This reduces the number of iterations on physical testing and avoids the discovery of design problems during testing, which is usually late in the development process and when making changes is the most expensive. But in the past, you had to still conduct the physical testing. With these new guidelines, you may now be able to submit simulation results to reduce the amount of required testing.
mm_model_stresses
Simulation to Identify Stresses and Loads on Critical Components While Manipulating a Surgical Device

Validation and verification using simulation has been part of the product development process in the aerospace industry for decades and has been very successful in increasing product performance and safety while reducing development costs.  It has proven to be a very effective tool, when applied properly.  Just as with physical testing, it is important that the virtual test be designed to verify and validate specific items in the design, and that the simulation makes the right assumptions and that the results are meaningful and accurate.

PADT is somewhat unique because we have broad experience with product development, various types of computational modeling and simulation, and the process of submission/approval with the FDA. In addition, we are ISO 13485 certified. We can provide the testing that is needed for the V&V process and employ simulation to accelerate and support that testing to help our medical device customers get their products to market faster and with less testing cost.  We can also work with customers to help them understand the proper application of simulation in their product development process while operating within their quality system.

Ulthera Purchased by Merz

Ulthera-Hand-Piece-SmallWe love to see our customers succeed – everyone here that has worked with Ulthera knew it would only be a matter of time before a large player recognized the value of this company. And, we just learned today that the German pharmaceutical company Merz is buying Ulthera for $600,000,000.  

Here is a link to an article on the sale, and here is a link to the press release

PADT worked with Ulthera to help them redesign their hand-piece design.  The process, called Ultherapy, is a non-surgical, non-invasive procedure for the face that uses high density, focused, ultrasound and the body’s own natural healing process to lift, tone, and tighten loose skin. Some of our employees also volunteered to test the device and pose for marketing material.  

Read about the work we did in a case study we published a while back.

Congratulations to everyone at Ulthera and we can’t wait to work with them again to help improve and grow this device and others in the future.

PADT Medical Team at AZBIO Expo 2014

Representatives of the PADT Medical team are having a great day at this years AZBIO Expo in Scottsdale.  We brought along some of the medical device projects we have worked on and have been chatting with past, current, and future customers.

Margaret and our “assistant” posed for this picture of the booth:AZBIO-2014-expo
Insert skeleton jokes here. 

The event is a fantastic reminder of how vibrant the local Bioscience community is in Arizona. From genetics to algae, pharma to med devices, the state has key players in almost every industry. And every year our three state universities make stronger and stronger contributions to basic research in this area.   There is a lot going on and this event is one of the best places to catch up on the wide ranging impact Arizona Bioscience companies are making. 

azbio-expo-icon-2014-long-1024x236

Ulthera Announces IPO

ultheraWe were pleased to note today that PADT Medical customer Ulthera Inc. filed for an $86M IPO with the SEC.  We have truly enjoyed working with this company offer our congratulations to them on reaching this major milestone.

You can read about the IPO in the Phoenix Business Journal here.
You can also read a case study on some of the work that PADT has done for Ultherea in the past here.

NeruoEM’s Featured in Phoenix Business Journal

It’s always nice when a customer gets a mention in the local press. PADT is helping NeruoEM in the development of a “a self-contained head device to prevent and treat Alzheimer’s Disease (AD) with electromagnetic waves.”  Check out the write-up here.  

There is not a lot we can say about the project or what we are doing for NeuroEM, but the website and article both give a good overview.

Needless to say, the older we all get, the more desire we have for this device to transition to an approved medical device. 

Pictures and Reflections from PADT’s 20th Anniversary Party

PADt-20-Logo-Rect-500wPADT held our 20th anniversary party at our primary offices in Tempe Arizona on April 10th. Despite the record high temperatures, around 400 people stop by to help us celebrate.  There was good food, good entertainment, and most importantly, good people.  

A highlight of the event is that April 10th was proclaimed PADT day in Tempe!  That was an unexpected honor.  

The only problem was not enough time to talk with everyone.  If you could not make it, no worries. We have several events planned throughout the year.

Here are some images that we captured:

Most of these pictures were taken by Aaron Moncur from PipelineDesign.

#padt20

Effective Engineering Outsourcing

The effective use of outsourced engineering resources is a strategy that many successful companies are learning how to employ and doing it correctly has become a critical competency . Outsourcing allows companies to adjust to variable workloads, infuse their products with new expertise, and accelerate time to market. Unfortunately outsourcing can be very frustrating, and like any core competency, the skills needed to outsource take time and effort for companies to acquire. Here are some simple pointers on how to develop your outsourcing competency with fewer headaches and less time.

When to OutsourceMedical device testing

Urgency – You have insufficient manpower to complete all your projects on time – and they all have important business ramifications. This is a time to consider outsourcing.

Temporary Need – If your lack of manpower seems to be ongoing – then hire permanent heads. If instead, the urgency you are feeling is temporary, consider outsourcing to get you through the crunch.

Expertise – If you would like to incorporate different expertise into your products, and don’t possess that competency as part of your core team, consider outsourcing to bring in fresh expertise or an expert only when you need them.

What to OutsourceSemiconductor equipment target CAD

Non-core activities – You need to keep your team focused on what they do best: your core capabilities. Projects that don’t require your internal expertise are good candidates for outsourcing.

Proof of concept – You would like to explore some novel new concept and don’t want to distract your team, this could be a good project to outsource.

Ancillary products – If you want to develop ancillary products that augment your main product line, this can offer an opportunity to define a well contained project that is good for outsourcing.

How to OutsourceProduct Development Process

Get multiple bids – You need to find outsourcing partners that match your requirements for expertise, speed, and cost. Get proposals from several contenders and remember that these proposals say a lot about how the project will go. Define the project clearly because if you want good results from your partners, you need to clearly define the scope of the project and the outcomes you are looking for.

Crawl, walk, run – Outsourcing is a challenging skill and you should expect to go through a learning curve. To keep your risks low, start with smaller and shorter projects and then work up to more complex ones.

Look Long Term – Find partners that can serve you long-term.

PADT Can HelpReviewing an electronic design

With over 50 engineers and 350 product development projects under our belt, PADT has tremendous experience and expertise to bring to bear on your problems. Let us show you how “We Make Innovation Work”

Customers and Partners Win at AZBio Awards and Pittsburgh Tech 50 for 2013

It is awards season and PADT partners and customers are racking up the wins around the country.

AZBio-Awards-2013-Header-10-10

On October 10th we were fortunate enough to be at the 2013 AZBio Awards where we were pleased to see:

  • The founder of customer Ventana Medical Systems,  Thomas M. Grogan, M.D, win a Lifetime Achievement Award.
  • Customer W. L. Gore and Associates picked up the Arizona Bioscience Company of the Year Award.
  • Linda Hunt, the President and CEO of Dignity Health Arizona received the Arizona Bioscience Leader of the Year award. The Barrow Neurological Institute, part of Dignity Health, is a PADT customer.

Not only were we pleased to see these winners, but once again PADT provided the trophies for these awards so they were able to take a little piece of PADT home with them.

AZ-Bio-Awards-2013

 

More images from the event can be found on their Facebook page.

Pittsburgh-tech-50-ANSYS-Alung-2013Then just today we received word that the Pittsburgh Technology Council announced the winners of their Tech 50 for 2013.  And once again, a PADT customer and one of our most important partner received an award.

  • Medical device customer ALung won the Life Sciences Company of the Year award.
  • ANSYS, Inc., a partner and customer, was awarded the Tech Titan Award for, well being a tech titan.

We offer our congratulations to all of the winners and hope to see more as the awards season continues.

If you want to win a few technology awards, maybe you should consider being a PADT customer… seems like a trend.

Four PADT Customers Named Finalists for MD+DI’s 2013 Medical Device Manufacturer of the Year

Orthosensor Medical DeviceLast week we found out that PADT’s long time co-located customer, Orthosensor, was named as a finalists in MD+DI’s 2013 Medical Device Manufacturer of the Year competition.  PADT has been working very closely with Orthosensor for many years with them actually putting a team inside PADT’s offices. We know they deserve recognition for the advances they have made. Congratulations!  This recognition not only underscores the technical and clinical successes of Orthosensor, it also highlights that commercial success they have had in partnering with industry leading orthopedic firms.

You can learn more about what PADT has done with Orthosensor by reading this case study.

The competition is pretty significant in the medical device industry and finalists and winners are chosen by the editing staff:

Each year, MD+DI recognizes one or more medical device companies that have risen above the crowd to advance medical device manufacturing. In looking at the field this year, we realized that the firms influencing the medical device business the most come from both within and outside the industry.

Some of our 10 finalists for the 2013 Medical Device Manufacturer of the Year are traditional device companies making waves with novel products and innovative business strategies; others are outsiders that are pushing boundaries by changing the definition of medical device manufacturing. We believe all of them are helping to evolve the industry.

– http://www.mddionline.com/article/2013-medical-device-manufacturer-year-finalists

There is a reader’s poll.  (Hint) We encourage everyone to take a look at the finalistsand voice their opinion (hint, hint) on who should get the award. And if they vote for Orthosensor, they will know they voted for a quality firm that has a close and long relationship with PADT. (Hint, hint, hint)

But wait, there is more! While getting the link for the Orthosensor mention, we were even more pleased to see first one, then two, then three other PADT customers listed. 40% of this years finalists are PADT customers.  That is something we are very proud of because it shows that we are working with customers that are really making a difference in peoples health:

  • Medtronic has been a long time prototyping and simulation services customer of PADT and we know that their wide array of life saving products really make a difference.
  • When Roche Diagnostics purchased long time customer Ventana Medical Systems we knew it would lead to great things. Now their tissue diagnostic systems are evolving faster and a wider range of customers have access to this very important tool in the daily struggle to battle cancer.  They also have one of the most beautiful campus locations of any of our customers. And since all the work we do for them is confidential, a picture of the campus will have to do.
  • Stratasys-PADTStratasys.  Yes that Stratasys. The company that PADT not only sells for but that is also a customer. You didn’t know they were also a customer? Stratasys purchases and bundles PADT’s SCA cleaning system for their Fused Deposition Modeling systems.To see Stratasys listed in this competition is a big deal for us, having used their technology for years to help our medical device customers.  We love the recognition that Rapid Prototyping (even if we have to call it 3D Printing) is getting these days for the real and substantial contribution it is making across industries.What is kind of cool in a rapid-prototyping-links-everything sort of way is that we have used Stratasys hardware to support all three of the device companies companies listed.

With four horses in this race we feel confident we will be congratulating one of them as this years winner!

Humbling Feedback from PADT’s Product Development Customers

Case-Studies-Screen-ShotWhen we decided to redo our website we were told by all of the experts that you need case studies and you need testimonials.  Being engineers, we immediately pushed back saying that none of our customers will give us the input we need.  We are happy to report that we were wrong. So wrong that we are humbled by the fantastic response.

Our initial effort is focused on documenting some of the projects we have done in our Product Development and Medical Device Development groups.  You can see the eleven case studies we currently have on our Successes page.  There is some good information there on how PADT helps companies develop their products.

But what we are most proud of are the awesome testimonials we have received directly from our customers.  We are usually not ones to brag and toot our own horn… but we were proud enough of these testimonials to where we felt it was OK to let them toot our horn for us.

“PADT did a great job translating our prototype ideas into a fully-designed, manufacturable product. From multi-disciplinary engineering to project management to fabrication, PADT did it all. PADT worked collaboratively with our team to understand requirements and to solve technical hurdles in order to deliver a product that best fit our expectations.”
– Garrett Beauregard, Senior VP of Engineering, ECOtality Inc.

“I found there to be great benefit in going through PADT’s disciplined steps for the development of an updated prototype of our device. Restarting with a more systematic approach, and analyzing each component fresh, made me feel confident about every aspect of the new design.”
– Neil R. Crawford, PhD Associate Professor, Spinal Biomechanics Barrow Neurological Institute

“PADT’s Design Team was instrumental in working with Orthosensor throughout the design and development activities of the Orthosensor Knee Balance. Their commitment and flexibility to our business needs allowed us to bring our product to market in a significantly shortened period of time.”
– Juan C Fernandez, COO, Orthosensor Inc

“SynCardia has chosen to work with PADT based on their ability to develop close personal relationships, to create and implement engineering solutions rapidly, and to support SynCardia’s innovative drive for our life-saving technology.”
— Douglas A Nutter, COO, SynCardia Systems, Inc.

“PADT has provided a number of valuable services for Ulthera ranging from design work and ergonomic improvements, to manufacturability and V&V testing. Over the past 18 months, PADT worked closely with our engineering staff to ensure the successful launch of our redesigned Deep See Handpiece. Our successful collaboration allowed us to focus our internal resources on our core competencies while leveraging PADT’s skill sets. Ulthera also benefited from PADT’s adaptable, customer-specific, Design Control process to minimize the QC documentation requirements on the Ulthera staff”
— Michael Peterson, Vice President, R&D, Ultherea, Inc

“For the last 2 years we have worked with PADT to develop our ClearView technology. Their team has helped us with many aspects of product development and commercialization. They have been a very valuable asset and I would highly recommend them to any startup that needs to navigate the pathway to market.”
— Tom Blondi, President, EPIC Research & Diagnostics

“PADT has demonstrated strong concept creation and development testing abilities – and have done so with very short time schedules. PADT was in charge of a key component development for our Fuel Cell System, and accomplished it as planned. Owing to PADT’s challenging spirit, Nissan was able to lease the 2005 model FCV’s to some customers in the early period of 2006. In addition, Nissan has been able to continue the FCV leasing program for five years with PADT’s reliable support.”
— Arai Takayuki, Senior Manager, EV Systems Laboratory, Nissan Motor Company

“The PADT experience was a positive one from my first phone conversation with them to the delivery of the end product. The engineers delivered a prototype that was exactly what I envisioned in a short 8 weeks. PADT will be my choice in the future.”
— Bob Rife, R.R.T.

“For the last 3 years I have worked with PADT Medical as a physician-inventor of medical devices. Their engineering team is professional, punctual, and responsible. Their management is exemplary. I recommend PADT Medical to any potential Client.”
— Charles J. Filipi M.D., Medical Director, SafeStitch Medical, Inc.

At PADT “We Make Innovation Work” and these fantastic testimonials give specific examples of how we have done that for others. If you would like to learn how PADT’s products and services can help you, please do not hesitate to contact us.

AZBioExpo 2013

PADT-AZBio-2013-Sponsors

Last week was AZBio Expo 20113 here in Tempe Arizona.  PADT was pleased to be a sponsor and we had a great time meeting with all of our customers and vendors at the event, as well as getting to chance to meet some new people. It is always an honor to be listed with so many great sponsors, and this event was no exception.

PADT-AZBio-2013-Booth

For our booth, we brought some examples of projects that we have done recently as well as one of our Stratasys Dimension 3D Printers, so that we could show off how we can make medical grade prototypes directly from CAD.

The highlight of the event was the keynote speech by Dr. Slepian from SynCardia spoke.    SynCardia is a customer that PADT has always been very proud to work with, and hearing about the progress that they are making was inspiring.

You can see other photos from the event on the AZBio Facebook page.